moving from r&d to manufacturing under sbir/sttr
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July 1, 2009. Moving From R&D To Manufacturing Under SBIR/STTR. Manufacturing Questions. Deciding if manufacturing is right for you & your company? When do you think about manufacturing & how relative to R&D activities Concepts in developing manufacturing processes - PowerPoint PPT PresentationTRANSCRIPT
M A N U F A C T U R I N G E X T E N S I O N P A R T N E R S H I P
NIH National SBIR Conference ‘09NIST MEP
Moving From R&D To Moving From R&D To Manufacturing Under SBIR/STTRManufacturing Under SBIR/STTR
July 1, 2009July 1, 2009
M A N U F A C T U R I N G E X T E N S I O N P A R T N E R S H I P
NIH National SBIR Conference ‘09 NIST MEP
Manufacturing QuestionsManufacturing Questions
Deciding if manufacturing is right for you & Deciding if manufacturing is right for you & your company?your company?
When do you think about manufacturing & how When do you think about manufacturing & how relative to R&D activitiesrelative to R&D activities
- Concepts in developing manufacturing processesConcepts in developing manufacturing processes
- Concepts in control of manufacturing processesConcepts in control of manufacturing processes
M A N U F A C T U R I N G E X T E N S I O N P A R T N E R S H I P
NIH National SBIR Conference ‘09 NIST MEP
What’s an “MEP”What’s an “MEP”
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NIH National SBIR Conference ‘09 NIST MEP
Do You Want To Manufacture?Do You Want To Manufacture?
M A N U F A C T U R I N G E X T E N S I O N P A R T N E R S H I P
NIH National SBIR Conference ‘09 NIST MEP
Exercise #1Exercise #1
1-2 Reasons why you might want to 1-2 Reasons why you might want to manufacture? – in 5 minsmanufacture? – in 5 mins
Work with partner to right, end of rows with Work with partner to right, end of rows with those behind youthose behind you
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NIH National SBIR Conference ‘09 NIST MEP
Developing Manufacturing Developing Manufacturing ProcessesProcesses
Design for manufacturabilityDesign for manufacturability
Concepts of “Vertical Integration”Concepts of “Vertical Integration”
Lean Manufacturing – “batch” versus “flow”Lean Manufacturing – “batch” versus “flow”
Value Stream Mapping (VSM)Value Stream Mapping (VSM)
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NIH National SBIR Conference ‘09 NIST MEP
NPD PerspectiveNPD Perspective
Phase II
Phase I
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NIH National SBIR Conference ‘09 NIST MEP
Manufacturing StrategiesManufacturing StrategiesRequired Investment, potential risk & skill Required Investment, potential risk & skill levelslevels
Process Process “Scaling” “Scaling” SkillsSkills
ManufacturinManufacturing Skill & g Skill & ExpertiseExpertise
Equipment Equipment Capital Capital InvestmentInvestment
Sales & Sales & DistributionDistribution
Manufacture Manufacture ““In-House”In-House” HighHigh HighHigh HighHigh HighHigh
Manufacture & Manufacture & AssembleAssemble MedMed HighHigh MedMed HighHigh
Manufacture Manufacture OutsourceOutsource LowLow LowLow LowLow HighHigh
LicenseLicense
LowLow LowLow LowLow LowLow
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NIH National SBIR Conference ‘09 NIST MEP
Manufacturing LevelsManufacturing LevelsPossible Application Versus NIH Clients - based on DOD MRL conceptshttps://www.mrlassist.bmpcoe.org/mrlassist/#
ML's Manufacturing Levels
4 Manufacturing demonstration
Materials, machines & tooling, inspection & test equipment demonstrated in laboratory environment. Producability
assessments initiated
5
Initial manufacturing plan developed. Manufacturing cost
drivers/goals identified, production costs estimated, yield/rate issues
identified, key quality characteristics identified. Significant
engineering/design changes.
6
Materials, machines & tooling demonstrated in relevant environment. But most
manufacturing processes in development. Production cost
drivers and goals analyzed & set. Signficant engineering/design
changes.
7
Pilot line manufacturing processes set up & under test. Processes &
procedures demonstrated in production relevant environment.
Design changes decreasing, production estimates being
established
8
Low-rate initial production. All materials & components identified
and available. Limited design changes. Manufacturing processes
& procedures proven on pilot line and under control. Producability
risks completed, production estimates meet production goals.
9 Manufacturing scale-up production
All manufacturing processes are established & meet three-sigma or some other quality level. Machine,
tooling, inspection and test equipment all deliver three-sigma or
other quality level in production.
10 Full scale productionFull scale production meeting six-
sigma or other quality levels as well as established production goals.
1 to 3
Manufacturing system development & testing
Manufacturing pilot & low-rate initial production
Manufacturing Concepts Identified Manufacturing Concepts 1-3 Concepts Established
4 Demonstration in laboratory
5 Overall plan Initiated
6 Demo in relevant environment
7 Pilot line established
8 Low-rate production runs
9 3 Sigma or better in production
10 Full-scale production
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NIH National SBIR Conference ‘09 NIST MEP
Exercise #2Exercise #2
Who will help you with developing your Who will help you with developing your manufacturing processes? – 5 mins?manufacturing processes? – 5 mins?
Work with person to your left, at end of row Work with person to your left, at end of row talk to person behind youtalk to person behind you
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Ambion, Inc., TexasAmbion, Inc., TexasBill Rafferty – TMAC StaffBill Rafferty – TMAC Staff
Bulk & custom manufacturing of kits, enzymes Bulk & custom manufacturing of kits, enzymes & reagents& reagents
Prototyping of racks in reagent kits, rapid Prototyping of racks in reagent kits, rapid prototyping, initial production, Lean 101 prototyping, initial production, Lean 101 training to reduce cycle times & inventorytraining to reduce cycle times & inventory
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Control of Manufacturing Control of Manufacturing ProcessesProcesses
““Open Market” Quality Control StandardsOpen Market” Quality Control Standards
- Systems versus RegistrationSystems versus Registration
Medical Market Quality Control StandardsMedical Market Quality Control Standards
- 510 K510 K
- Good Manufacturing Practices (GMP)Good Manufacturing Practices (GMP)
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NIH National SBIR Conference ‘09 NIST MEP
Wavefront Sciences, New Wavefront Sciences, New MexicoMexicoRon Burke – NMEP StaffRon Burke – NMEP Staff
Wavefront sensing metrology Wavefront sensing metrology (such as detailed (such as detailed measurements for LASIK survery)measurements for LASIK survery)
Tech Transfer from Sandia National LabsTech Transfer from Sandia National Labs
Public seminars on Lean Principles, plant Public seminars on Lean Principles, plant layout assistance as they expanded, ISO and layout assistance as they expanded, ISO and GMP auditing assistanceGMP auditing assistance
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NIH National SBIR Conference ‘09 NIST MEP
NIH MAP Project Areas
0
2
4
6
8
10
12
14
ImpQual
Scale-up
Protype EquipSpecs
ProdCost
FacilityLay
SupplierIdent
Project Types
Num
ber
of P
roje
cts
Pilot Round
2nd Round
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NIH National SBIR Conference ‘09 NIST MEP
Contact InformationContact Information
http://www.mep.nist.gov/http://www.mep.nist.gov/
Tab WilkinsTab WilkinsAccount Manager & Senior Technology AdvisorAccount Manager & Senior Technology Advisor(301) 646-4069(301) [email protected]@nist.gov